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New treatment option for PIK3CA Mutation
Official title First-in-Human Study of Mutant-selective PI3Kα Inhibitor, RLY-2608, as a Single Agent in Patients With Advanced Solid Tumors and in Combination With Endocrine Therapy +/- a CDK4/6 or CDK4 Inhibitor in Patients With Advanced Solid Tumors or Advanced Breast Cancer
ClinicalTrials.gov ID: NCT05216432
What this study is testing
What is RLY-2608?
RLY-2608 is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for pik3ca mutation.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This is an open-label, FIH study designed to evaluate the maximum tolerated dose, recommended Phase 2 dose, safety, tolerability, PK, pharmacodynamics, and preliminary antineoplastic activity of RLY-2608, in advanced solid tumor patients with a Phosphatidylinositol-4,5-bisphosphate-3 kinase, catalytic subunit alpha (PIK3CA) mutation in blood and/or tumor per local assessment. The study will evaluate RLY-2608 as a single agent for patients with unresectable or metastatic solid tumors.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Key Patient has ECOG performance status of 0-1 One or more documented primary oncogenic PIK3CA mutation(s) in blood and/or tumor per local assessment...
- [For Part 1: Escalation]: Evaluable disease per RECIST v1.1
- [For Part 2: Expansion]: Measurable disease per RECIST v1.1
- Disease that is refractory to standard therapy, intolerant to standard therapy, or has declined standard therapy.
- Part 1- histologically or cytologically confirmed diagnosis of unresectable or metastatic solid tumor
You likely can't join if
- Prior treatment with:
- PI3Kα, AKT, or mTOR inhibitors (all arms except for doublet RLY-2608 + fulvestrant arm, Part 2, Group 2; and triplet combinations, Part 1 dose...
- Immune checkpoint inhibitors.
- Triplet combinations RLY-2608 + CDK4 or CDK4/6 inhibitor + fulvestrant, Part 2 expansion, Group 2 only: i. Prior systemic chemotherapy or antibody...
- Mean resting corrected QT interval (QTc) \>460 msec
- For triple combination arm with ribociclib: Mean QTcF ≥450 msec (this is what we confirmed is shown in the redacted version of the protocol. CNS...
See the full eligibility criteria
- Key Patient has ECOG performance status of 0-1 One or more documented primary oncogenic PIK3CA mutation(s) in blood and/or tumor per local assessment Other potentially oncogenic PIK3CA mutations may be considered but...
- [For Part 1: Escalation]: Evaluable disease per RECIST v1.1
- [For Part 2: Expansion]: Measurable disease per RECIST v1.1
- Disease that is refractory to standard therapy, intolerant to standard therapy, or has declined standard therapy.
- Part 1- histologically or cytologically confirmed diagnosis of unresectable or metastatic solid tumor
- Part 2 - Unresectable or metastatic solid tumor with PIK3CA mutation(s) and one of the following tumor types: Group 1: clear cell ovarian cancer Group 2: head and neck squamous cell carcinoma Group 3: cervical cancer...
- Doublet combination arms [Part 1 and Part 2]: Evaluable disease per RECIST v1.1
- Triplet combination arms:
- [Part 1 and Part 2 Dose Expansion, Group 1]: Evaluable disease per RECIST.
- [Part 2 Dose Expansion, Group 2]: Measurable disease per RECIST. Bone-only lytic or lytic/blastic disease with at least 1 measurable soft-tissue component per RECIST may be eligible.
- [For Part 1 and Part 2]: Male or female with histologically or cytologically confirmed diagnosis of HR+, HER2- unresectable or metastatic breast cancer that is not amenable to curative therapy. Females may be...
- Had previous treatment for breast cancer with: [Does not apply to triplet combination arms, Part 2 Dose Expansion, Group 2]:
- ≤1 line of chemotherapy in the metastatic setting
- ≥1 CDK4/6 inhibitor in either the adjuvant and/or metastatic setting
- ≥1 antiestrogen therapy in either adjuvant and/or metastatic setting, including, but not limited to, selective estrogen-receptor degraders (eg, fulvestrant), selective estrogen receptor modulators (eg, tamoxifen), and...
- ≥1 PARP inhibitor, if appropriate, if documented germline BRCA1/2 mutation Note: Systemic local, loco-regional, or adjuvant treatment with chemotherapy and PARP inhibitors is not to be included in enumeration or...
- Participants must have progressed during (neo)adjuvant endocrine therapy or within12 months of completing (neo)adjuvant endocrine therapy with an AI or tamoxifen.
- If a CDK4/6 inhibitor was included as part of (neo)adjuvant therapy, disease must have recurred/progressed \>12 months after completion of the CDK4/6 inhibitor portion of (neo)adjuvant therapy Key
- Prior treatment with:
- PI3Kα, AKT, or mTOR inhibitors (all arms except for doublet RLY-2608 + fulvestrant arm, Part 2, Group 2; and triplet combinations, Part 1 dose escalation).
- Immune checkpoint inhibitors.
- Triplet combinations RLY-2608 + CDK4 or CDK4/6 inhibitor + fulvestrant, Part 2 expansion, Group 2 only: i. Prior systemic chemotherapy or antibody drug conjugate for locally advanced or metastatic disease. ii. Prior...
- Mean resting corrected QT interval (QTc) \>460 msec
- For triple combination arm with ribociclib: Mean QTcF ≥450 msec (this is what we confirmed is shown in the redacted version of the protocol. CNS metastases or primary CNS tumor that is associated with progressive...
The study team makes the final eligibility decision.
Where it's taking place
- Tucson, Arizona, United States
- San Diego, California, United States
- Denver, Colorado, United States
- New Haven, Connecticut, United States
- Orlando, Florida, United States
- Plantation, Florida, United States
- Chicago, Illinois, United States
- Indianapolis, Indiana, United States
- Boston, Massachusetts, United States
- Ann Arbor, Michigan, United States
- St Louis, Missouri, United States
- Reno, Nevada, United States
- New Brunswick, New Jersey, United States
- New York, New York, United States
- Nashville, Tennessee, United States
- Dallas, Texas, United States
- Houston, Texas, United States
- Salt Lake City, Utah, United States
- Fairfax, Virginia, United States
- Madison, Wisconsin, United States
+ 11 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Tucson, Arizona, United States; San Diego, California, United States; Denver, Colorado, United States; New Haven, Connecticut, United States; Orlando, Florida, United States; Plantation, Florida, United States and 25 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.